Background: Functional tricuspid regurgitation due to annular and ventricular dilatation is increasingly recognized as a significant source of morbidity and mortality. To repair the annulus, surgeons implant one of many annuloplasty devices that differ in size, 3-dimensional (3D) shape, and stiffness. However, there have been no quantitative comparisons between various available devices.
Methods: Three-dimensional scanning, micro-computed tomography imaging, analytical methods, and mechanical tests were used to compare 3 Edwards Lifesciences (Irvine, CA) and 3 Medtronic (Minneapolis, MN) annuloplasty devices of all available sizes. We measured in-plane metrics of maximum diameter, perimeter, area, height, as well as elevation and curvature profiles. Furthermore, we computed bending stiffness as well as the maximum and minimum axes of the bending stiffness.
Results: Most annular prostheses differed little in their in-plane geometries but varied significantly in height. In-plane properties deviated significantly from measurements of healthy human tricuspid annuli. Height of the Edwards' MC3 and Medtronic's Contour 3D resembled healthy human tricuspid valve annuli, whereas the Edwards' Physio and Classic, and Medtronic's TriAd, did not. Additionally, the elevation profiles of the MC3 and Contour 3D and curvature profiles between all devices were consistent and matched those of healthy human annuli. The tested devices also differed in their bending stiffness, both in terms of absolute values and their maximum and minimum axes.
Conclusions: Contoured devices, such as Edwards' MC3 and Medtronic's Contour 3D, most accurately resembled the healthy human tricuspid annulus but differed significantly in bending stiffness. To what extent prosthesis properties and shape affect tricuspid valve function remains to be determined.
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